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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON & CO. / CAREFUSION 2200, INC. CURETTE

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BECTON DICKINSON & CO. / CAREFUSION 2200, INC. CURETTE Back to Search Results
Lot Number AP37545
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
Event Type  malfunction  
Event Description
A curette handle from the rongeur tray breaks completely in half while md is using on the patient.Md was twisting the instrument and the handle broke.No apparent harm done to the patient.Fda safety report id # (b)(4).
 
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Brand Name
CURETTE
Type of Device
CURETTE
Manufacturer (Section D)
BECTON DICKINSON & CO. / CAREFUSION 2200, INC.
MDR Report Key12934893
MDR Text Key281906346
Report NumberMW5105828
Device Sequence Number1
Product Code HTF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberAP37545
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
Patient SexMale
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